Disposable drainage pouch for colostomy and the like and method of making

ABSTRACT

This invention provides a drainage pouch for use in the medical field in caring for patients having colostomy conditions and the like, characterized by a pouch of plastic film such as polyethylene, a ring-shaped retainer positioned inside the pouch and united to the inner side thereof around its stoma opening, the internal edge of the retainer being covered by an annular portion of the film pressed into the pouch to provide a protective wall which prevents the retainer from cutting and injuring the stoma; together with a method of making the pouch which promotes low cost of manufacture and provides a pouch so economical in cost as to be entirely disposable after a single use.

States Patent Unite [15] 3,695,268 Marsan 51 Oct. 3, 1972 [541 DISPOSABLE DRAINAGE POUCH FOR OTHER PUBLICATIONS COLOSTOMY AND THE LIKE AND METHOD OF MAKING [72] Inventor: Arthur E. Marsan, 1265 S. Bellare St., Denver, Colo. 80222 [22] Filed: June 5, 1970 [21] Appl. N0.: 43,676

[52] US. Cl ..l28/283 [51] Int. Cl. ..A61f 5/44 [58] Field of Search 128/283, 295

[56] References Cited UNITED STATES PATENTS 2,684,675 7/1954 Perry ..12s/2s3 2,703,576 3/1955 Furr, Jr 128/283 2,741,247 4/1956 Marsan 128/283 2,837,094 6/1958 Cowles ..128/283 3,006,343 10/1961 Baxter ..l28/283 3,021,843 2/1962 Perry ..128/283 FOREIGN PATENTS OR APPLICATIONS 969,749 9/ 1964 Great Britain Surgery, Gyn & Ob, Nov. 1951 pp. 558- 559.

Primary Examiner-Charles F. Rosenbaum Attorney-John F. McCanna ABSTRACT This invention provides a drainage pouch for use in the medical field in caring for patients having colostomy conditions and the like, characterized by a pouch of plastic film such as polyethylene, a ring-shaped retainer positioned inside the pouch and united to the inner side thereof around its stoma opening, the internal edge of the retainer being covered by an annular portion of the film pressed into the pouch to provide a protective wall which prevents the retainer from cutting and injuring the stoma; together with a method of making the pouch which promotes low cost of manufacture and provides a pouch so economical in cost as to be entirely disposable after a single use.

12 Claims, 5 Drawing Figures DISPOSABLE DRAINAGE POUCH FOR COLOSTOMY AND THE LIKE AND METHOD OF MAKING This invention relates to drainage pouches used with ostomy" patients having conditions known as colostomy and ileostomy, and the like. The needs and requirements for these patients vary considerably according to the conditions of the individual patients. For example, the differences in physical stature and age of the patients; the location of the surgery in the intestinal tract and the varying dimensions of the intestines; and the varying surgical performances. In view of the many variables there have been numerous drainage pouches and appliances provided for these needs. Some of the prior devices are unsatisfactory because of sanitary conditions incident to the requirement of removing from the device after use parts such as belts and reinforcement gaskets, for washing and re-use. This requires special work and is not in the interest of sanitary care, convenience, and time-saving for the nurses and others who care for the patients. Also, because our society is undergoing great changes, the cost of caring for these patients is increasing.

Therefore, one of the objects of my invention is to advance this art by the provision of improvements which promote lower cost of manufacturing drainage pouches and which overcome many of the objections inherent in and incident to the use of prior devices.

Another object to provide a drainage pouch of such improved construction as to be economical for disposal of the complete device after a single use. By this I mean disposal not only of the pouch, but the belt as well, thus eliminating the work and care heretofore required by nurses and others in removing belts and other parts for washing and re-using.

Another object is to provide a drainage pouch characterized by its few parts, essentially a pouch bag having in one side a stoma opening, a ring-shaped retainer positioned inside the bag and united to said side around the stoma opening, with said side formed to extend into the bag and cover the internal edge of the retainer and thereby protect the stoma against cutting and injury by said edge of the retainer, together with a belt fixed to the retainer in a manner to hold the pouch against the abdomen of the patient when in use.

Another object of the invention is to provide a drainage pouch having an improved belt construction whereby the belt is permanently united to the pouch and its retainer and serves effectively to hold the pouch in position on the patient without breaking the retainer connection, and whereby the cost of the device as a whole is lowered so as to promote economy and permit disposal of the entire device after each single use.

Another object is to provide an improved method of manufacturing drainage pouches, whereby to promote lower cost of manufacturing and greater satisfaction in the use of these pouches.

Other objects and attendant advantages will be appreciated by those skilled in this art as the invention becomes better understood by reference to the following specifications and claims together with the appended drawings, in which:

FIG. 1 is a face view looking at the inner side of a drainage pouch embodying my invention;

FIG. 2 is a section taken on the section line 2--2 of FIG. 1;

FIG. 3 is a section, an enlargement of the stoma opening portion of FIG. 2, showing in dotted lines a heated plug used in making the pouch;

FIG. 4 shows the blanking of three retainer sizes for a single sheet; and

FIG. 5 shows the attachment of a belt to the largest size retainer.

In view of the many variables in the conditions of the patients as briefly outlined above, it has been the practice in this field to provide devices having stoma openings of different sizes. Also, it has been the practice where parts of the devices such as the drainage pouch or bag are disposable after use, to remove some of the more costly parts and wash them for reuse. My invention contemplates improvements both in the cost of drainage pouches and in their use, as mentioned in the objects prefaced above. In furtherance of these objects l have provided a pouch device which is completely disposable after a single use. As shown in FIGS. 1, 2 and 3, the pouch device comprises a pouch bag 6, a retainer 7, and a belt 8, these reference numerals designating the parts generally. The retainer 7 which surrounds the stoma-receiving opening 9 in a side wall of the pouch is ring-shaped of a size suitable for receiving the stoma. As a preferred embodiment this retainer is cut to shape from a sheet of cardboard. In FIG. 4 is shown a cardboard sheet 11 cut by suitable stamping dies to form a plurality of individual retainers, namely, a large size retainer 12 having a large stoma opening 13, an intermediate retainer of the size 7 (shown in FIG. 1) having a stoma opening 14, and a smallsize retainer 15 having a small stoma opening 16. The stoma opening sizes could range from approximately 1 inch to 3% inches in diameter. More than three retainer sizes could be made from a single sheet. A considerable saving in cost of manufacture per unit is made with this method.

Referring now to the pouch or bag 6, this is preferably of plastic film such as polyethylene of suitable thickness. While other film material could be used, polyethylene is preferred because of its low cost and also because it permits the use of heat sealing to secure all the components into a complete product, as will be presently described. Also, to provide for odor barrier a sheet of vinylidene chloride film (commonly known as Saran) may be interposed between sheets of polyethylene film. This laminated film increases the cost but may be desired in some special conditions. Odor barrier may also be provided by spraying the polyethylene fihn walls inside or spraying them outside after the pouch is completed. The pouch in its flattened condition has two side walls referred to for clarity of description as an inner side wall 17 and an outer side wall 18. The stoma opening 9 in the inner side wall is preferably circular. The retainer 7 is positioned inside the pouch in registration with the stoma opening and united to the inner side of the inner side wall continuously around said opening. I prefer to coat the retainer on both sides with polyethylene. This improves the resistance of the cardboard to water in the fecal discharge and it also allows the retainer to be heat sealed to the film wall of the pouch. The retainer could be made of other materials instead of cardboard. For example, solid polyethylene could be used in sheet form and die cut into ring shapes as described with reference to FIG. 4. The retainer could be composed of other materials. Also, it could be molded as by the use of polyethylene granules. It should be understood, therefore, that the term cardboard" is used in the specification and claims as meaning any sheet material which is die cut to shape and would serve the purpose of a retainer.

It will now be noted that the film of the inner side wall 17 has an annular marginal portion 21 extending beyond the internal edge 22 of the retainer. This marginal portion 21 is turned inwardly into the pouch so as to cover the retainer, particularly the internal edge 22 thereof entirely around the central opening. I prefer to form this cover by using an annular hot plug 23 indicated by dotted lines in FIG. 3. This heated plug shapes the thermoplastic film portion 21 permanently. This cover portion provides a protective wall around the stoma when the stoma enters the pouch and also while it is in the pouch. Said cover portion serves to protect the stoma from being cut or injured by the internal edge of the retainer. Cutting the stoma could cause bleeding.

The pouch is closed by heat sealing the side walls 17 and 18 continuously along their edges 24, 25, 26 and 27, where two separate side wall sheets are used. However, the pouch could be made using a single film sheet, folding one side over the other.

Referring now to attaching the pouch to the abdomen of the patient with the stoma in position within the pouch: My invention provides a belt combined in a novel manner with the pouch and its retainer. I prefer to use a belt in two lengths, each permanently united at one end to the outside of the pouch and to the retainer in a manner to prevent tearing or breaking the connection or the retainer under the most severe stresses and strains encountered in the use of these pouches. This belt is fabricated of plastic material to provide a thin, fibrous, porous, non-woven sheet. It is preferably made from spun, bonded polythylene fibers. Such material is known as Tyvek. It has high strength. When the belt is applied the pores between the fibers allow the skin to breath, thus preventing perspiration build-up between the belt and the patient. The ends 28 and 29 of the belt fit flat against the outside of the inner side wall 17 at diametrically opposite sides of the retainer and are heat sealed to the retainer and to said wall as by fusing entirely through said said wall and the retainer body. This heat sealing is at circular flat spots 31 and 32. This makes a permanent, integral connection of the belt to the pouch and the retainer. After the pouch is applied to the abdomen with the stoma inserted, the loose ends of the belt will be wrapped flat around the patient, pulled taught to hold the pouch tight against the abdomen, and tied as a knot or bow. Instead of tying the ends of the belt they could be secured together with a pressure sensitive tape, or an adhesive could be applied to one or both ends of the belt. In FIG. I have shown a pouch having a larger retainer such as 12 shown in FIG. 4. Here the belt end is split into three terminal ends 33, 34 and 35, which are connected to the pouch and retainer at spaced points to better distribute the lines of force when the belt is holding the pouch onthe patient. Each split end of the belt is heat sealed to the pouch and to the retainer at a spot such as 36 similar to the heat seals 3132 above described. This split end is, of course, applied to each diametrically opposite side of the retainer, similar to the belt connections in FIG. 1.

As further illustrative of materials to be used in the manufacture of drainage pouches according to my invention, the polyethylene film may be of varying thickness, for example, from 0.0015 inch to 0.002 inch, and the retainer cardboard from 0.015 inch to 0.022 inch. As to the belt, materials other than Tyvek may be used, such as spunbonded polyesters, polypropylene, high density ethylene homoplymers, polyvinye chloride and polystyrene. These specifications are intended to illustrate the broad concept of materials adapted to be used in the practice of my invention, and not as limitations.

From the foregoing it will be apparent that the drainage pouch as a unitary article of manufacture consisting of components pouch bag, retainer, and belt, is a simple and low cost construction, whereby it is economical and may be completely disposed of after each single use. This eliminates many undesirable conditions incident to the use of prior drainage pouches. Also, this construction serves well the drainage function and the stoma is protected against cutting and injury by contact with the edges of retainer and gasket parts.

It is believed that the foregoing conveys a clear understanding of my invention; and it will be apparent that changes may be made in materials and details of construction within the spirit and scope of the appended claims, in which,

I claim:

1. A drainage pouch for colostomy and the like, in which the pouch has an inner wall and an outer wall of plastic film material, the inner film wall adapted to be positioned against the abdomen of the patient and having a circular stoma receiving opening, a retainer of flat material die cut to shape having a circular stoma receiving opening, the retainer positioned inside the pouch and aflixed to the inner side of the inner wall with its stoma opening in registration with the stoma in said inner film wall, the inner diameter of the retainer opening being greater than the diameter. of the stoma opening whereby the inner film wall provides a marginal wall of the film material extending around the stoma opening in the retainer, said marginal film wall turned inwardly into the pouch to cover the inner die cut edge of the retainer opening and prevent the retainer from cutting or injuring the stoma.

2. A drainage pouch as set forth in claim 1, in which the retainer is heat sealed to the inner side of the inner film wall.

3. A disposable drainage pouch for colostomy and the like comprising a pouch, a retainer member, and a belt, the pouch having spaced walls one of which has a circular opening for receiving a stoma, the retainer member being of flat material die cut to shape having a circular stoma opening and positioned at the inside of the pouch with its circular opening in registration with that in the pouch wall and affixed to the inside of said pouch wall; said stoma opening wall turned inwardly into the pouch entirely around the die cut edge of the retainer opening to provide a stoma protecting wall covering the entire die cut edge of the retainer opening, the belt having ends fixed to the pouch and to the retainer at diametrically opposite sides of the stoma opening adapted to encircle the waist of the patient and hold the pouch against the abdomen with the stoma extending into the pouch through said stoma opening.

4. A drainage pouch for colostomy and the like comprising a pouch bag having an inner side wall and an outer side wall, the inner side wall having a stoma opening, a retainer positioned inside the pouch bag having a stoma opening registering with that in the inner side wall, and a belt having its ends heat sealed to the inner side wall of the bag and through to the retainer at diametrically opposite sides of the stoma openings, the connection of each belt end comprising means uniting together as a unit the belt end, the retainer, and the intermediate inner side wall.

5. A drainage pouch as set forth in claim 4, in which each belt end terminates in a widened portion and the means uniting the belt end is applied at said widened portion to the pouch bag and to the retainer at points spaced apart laterally with respect to the longitudinal axis of the belt.

3 6. As an article of manufacture, a drainage pouch for colostomy and the like, having components comprising a pouch bag of plastic material, a ring-shaped retainer, and a belt of plastic material, the pouch bag having a stoma-receiving opening, the retainer affixed to said side of the pouch bag having an internal edge portion surrounding the stoma opening thereof, means covering said internal edge portion entirely around the stoma opening preventing contact of said edge portion with a stoma, the belt having end portions positioned at diametrically opposite sides of the retainer and heat sealed to the pouch bag and the retainer whereby said components are permanently united as a single article.

7. An article of manufacture as set forth in claim 6, in which the pouch bag is of polyethylene, the retainer is of cardboard coated with polyethylene, and the belt is of a material fusible by the application of heat,

8. A drainage pouch for colostomy conditions and the like, comprising a pouch of plastic film having an inner side wall and an outer side wall, the inner side wall having a circular stoma receiving opening, a retainer of flat cardboard-like material die cut to shape having a circular stoma receiving opening, the retainer positioned inside the pouch flat against the inner side wall thereof with its circular opening in registration with the circular opening in said side wall, the film of said inner wall having a marginal portion around its circular opening extending inwardly covering the internal edge of the die cut circular opening in the retainer entirely around said opening, whereby to protect the stoma from injury by contact with said die cut edge when the pouch is in use on a patient.

9. A drainage pouch for colostomy and the like, in which the pouch has an inner wall and an outer wall of plastic film material, the inner film wall adapted to be positioned against the abdomen of the patient and having a stoma receiving opening, a ring-shaped retainer positioned inside the pouch and affixed to the inner side of the inner wall around its stoma opening, the inner diameter of the retainer being greater than the diameter of the stoma opening whereby the inner film wall provides a marginal wall of film material extending around the stoma opening, said marginal film wall turned inwardly into the pouch whereby to cover the inner edge of the retainer and prevent the retainer from 'cutting or injuring the stoma, the retainer being heat sealed to the inner side of the inner film wall, and infilm wall and to the retainer at diametrically opposite sides thereof.

10. A disposable drainage pouch for colostomy and the like comprising a pouch, a retainer member, and a belt, the pouch having spaced walls one of which has an opening for receiving a stoma, the retainer member shaped to surround the stoma opening and positioned at the inside of the pouch and affixed to the inside of the wall having the stoma opening, said stoma opening wall turned inwardly into the pouch entirely around the inner edge of the retainer so as to provide a stoma protecting wall covering the entire inner edge of the retainer, the belt having ends fixed to the pouch and to the retainer at diametrically opposite sides of the stoma opening adapted to encircle the waist of the patient and hold the pouch against the abdomen with the stoma extending into the pouch through said stoma opening, the pouch being of polyethylene film, the retainer being of cardboard coated with polyethylene and heat sealed to the inner side of the pouch wall, and the belt being of fusible material with its ends heat sealed to the outside of the pouch and through to heat seal with the retainer.

11. As an article of manufacture, a drainage device for colostomy and the like comprising components, namely, a drainage pouch having a stoma-receiving opening, retainer means surrounding said opening, and a belt of fusible material having ends heat sealed to the pouch and the retainer means whereby to fixedly secure all the components into a complete unitary article which promotes economy in cost of manufacture and permits disposal of the complete article after a single use.

12. As an article of manufacture, a drainage device for colostomy and the like having a drainage pouch provided with a stoma-receiving opening, and a belt of fusible material having ends heat sealed in connection with the pouch, the belt adapted to encircle the patients waist and hold the pouch against the patient's abdomen with the stoma passing through said opening when the device is in use on the patient, said heat sealing fixed securing the belt and the pouch in a unitary article of manufacture disposable after a single use. 

1. A drainage pouch for colostomy and the like, in which the pouch has an inner wall and an outer wall of plastic film material, the inner film wall adapted to be positioned against the abdomen of the patient and having a circular stoma receiving opening, a retainer of flat material die cut to shape having a circular stoma receiving opening, the retainer positioned inside the pouch and affixed to the inner side of the inner wall with its stoma opening in registration with the stoma in said inner film wall, the inner diameter of the retainer opening being greater than the diameter of the stoma opening whereby the inner film wall provides a marginal wall of the film material extending around the stoma opening in the retainer, said marginal film wall turned inwardly into the pouch to cover the inner die cut edge of the retainer opening and prevent the retainer from cutting or injuring the stoma.
 2. A drainage pouch as set forth in claim 1, in which the retainer is heat sealed to the inner side of the inner film wall.
 3. A disposable drainage pouch for colostomy and the like comprising a pouch, a retainer member, and a belt, the pouch having spaced walls one of which has a circular opening for receiving a stoma, the retainer member being of flat material die cut to shape having a circular stoma opening and positioned at the inside of the pouch with its circular opening in registration with that in the pouch wall and affixed to the inside of said pouch wall; said stoma opening wall turned inwardly into the pouch entirely around the die cut edge of the retainer opening to provide a stoma protecting wall covering the entire die cut edge of the retainer opening, the belt having ends fixed to the pouch and to the retainer at diametrically opposite sides of the stoma opening adapted to encircle the waist of the patient and hold the pouch against the abdomen with the stoma extending into the pouch through said stoma opening.
 4. A drainage pouch for colostomy and the like comprising a pouch bag having an inner side wall and an outer side wall, the inner side wall having a stoma opening, a retainer positioned inside the pouch bag having a stoma opening registering with that in the inner side wall, and a belt having its ends heat sealed to the inner side wall of the bag and through to the retainer at diametrically opposite sides of the stoma openings, the connection of each belt end comprising means uniting together as a unit the belt end, the retainer, and the intermediate inner side wall.
 5. A drainage pouch as set forth in claim 4, in which each belt end terminates in a widened portion and the means uniting the belt end is applied at said widened portion to the pouch bag and to the retainer at points spaced apart laterally with respect to the longitudinal axis of the belt.
 6. As an article of manufacture, a drainage pouch for colostomy and the like, having components comprising a pouch bag of plastic material, a ring-shaped retainer, and a belt Of plastic material, the pouch bag having a stoma-receiving opening, the retainer affixed to said side of the pouch bag having an internal edge portion surrounding the stoma opening thereof, means covering said internal edge portion entirely around the stoma opening preventing contact of said edge portion with a stoma, the belt having end portions positioned at diametrically opposite sides of the retainer and heat sealed to the pouch bag and the retainer whereby said components are permanently united as a single article.
 7. An article of manufacture as set forth in claim 6, in which the pouch bag is of polyethylene, the retainer is of cardboard coated with polyethylene, and the belt is of a material fusible by the application of heat.
 8. A drainage pouch for colostomy conditions and the like, comprising a pouch of plastic film having an inner side wall and an outer side wall, the inner side wall having a circular stoma receiving opening, a retainer of flat cardboard-like material die cut to shape having a circular stoma receiving opening, the retainer positioned inside the pouch flat against the inner side wall thereof with its circular opening in registration with the circular opening in said side wall, the film of said inner wall having a marginal portion around its circular opening extending inwardly covering the internal edge of the die cut circular opening in the retainer entirely around said opening, whereby to protect the stoma from injury by contact with said die cut edge when the pouch is in use on a patient.
 9. A drainage pouch for colostomy and the like, in which the pouch has an inner wall and an outer wall of plastic film material, the inner film wall adapted to be positioned against the abdomen of the patient and having a stoma receiving opening, a ring-shaped retainer positioned inside the pouch and affixed to the inner side of the inner wall around its stoma opening, the inner diameter of the retainer being greater than the diameter of the stoma opening whereby the inner film wall provides a marginal wall of film material extending around the stoma opening, said marginal film wall turned inwardly into the pouch whereby to cover the inner edge of the retainer and prevent the retainer from cutting or injuring the stoma, the retainer being heat sealed to the inner side of the inner film wall, and including a belt fusible with the plastic film material and having ends heat sealed to the outer side of the inner film wall and to the retainer at diametrically opposite sides thereof.
 10. A disposable drainage pouch for colostomy and the like comprising a pouch, a retainer member, and a belt, the pouch having spaced walls one of which has an opening for receiving a stoma, the retainer member shaped to surround the stoma opening and positioned at the inside of the pouch and affixed to the inside of the wall having the stoma opening, said stoma opening wall turned inwardly into the pouch entirely around the inner edge of the retainer so as to provide a stoma protecting wall covering the entire inner edge of the retainer, the belt having ends fixed to the pouch and to the retainer at diametrically opposite sides of the stoma opening adapted to encircle the waist of the patient and hold the pouch against the abdomen with the stoma extending into the pouch through said stoma opening, the pouch being of polyethylene film, the retainer being of cardboard coated with polyethylene and heat sealed to the inner side of the pouch wall, and the belt being of fusible material with its ends heat sealed to the outside of the pouch and through to heat seal with the retainer.
 11. As an article of manufacture, a drainage device for colostomy and the like comprising components, namely, a drainage pouch having a stoma-receiving opening, retainer means surrounding said opening, and a belt of fusible material having ends heat sealed to the pouch and the retainer means whereby to fixedly secure all the components into a complete unitary article which promotes economy in cost of manufacture And permits disposal of the complete article after a single use.
 12. As an article of manufacture, a drainage device for colostomy and the like having a drainage pouch provided with a stoma-receiving opening, and a belt of fusible material having ends heat sealed in connection with the pouch, the belt adapted to encircle the patient''s waist and hold the pouch against the patient''s abdomen with the stoma passing through said opening when the device is in use on the patient, said heat sealing fixed securing the belt and the pouch in a unitary article of manufacture disposable after a single use. 